title: [Double-blind parallel-group dose-titration study comparing a fentanyl-containing patch formulated for 1-day application for the treatment of cancer pain with Durotep MT Patch].
abstract: BACKGROUND
  The efficacy and safety of a fentanyl-containing patch formulated for 1-day application at the initiation and during continuous treatment of cancer pain were evaluated in patients previously untreated with opioid analgesics.
  
  
  METHODS
  In the dose-titration period (Period I), the 1-day formulation (0.84 mg x day(-1)) was applied for 2 days. If pain relief was insufficient, the dose was titrated, and the success rate was evaluated. In the double-blind period (Period II), the efficacies of the 1-day and the 3-day formulations for pain control were compared.
  
  
  RESULTS
  The dose-titration success rate of the 1-day formulation was 80.6%, and its analgesic effect was comparable to that of the 3-day formulation. Moreover, tolerability of the 1-day formulation was good. Adverse events occurring in the patients were those generally seen after treatments with opioid analgesics, and severe symptoms were also reported.
  
  
  CONCLUSIONS
  Dose titration of the 1-day formulation was accomplished in a short period in patients with cancer pain who had been previously untreated with opioid analgesics; the efficacy of the formulation for pain control after repeated dosing was comparable to that of the 3-day formulation, and its tolerability was good. However, it was considered that the 1-day formulation should be used in patients with good tolerability to opioid analgesics. Further, for safety reasons, the dose should not be increased for at least 2 days after the initial application and the last dose increase.
authors.affiliation: Department of Anesthesiology and Pain Relief Center, JR Tokyo General Hospital, Tokyo 151-8528.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Hanaoka
authors.forename: Takashi
authors.initials: T
authors.lastname: Yoshimura
authors.forename: Tomoyasu
authors.initials: T
authors.lastname: Tomioka
authors.forename: Hideo
authors.initials: H
authors.lastname: Sakata
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000097:blood*; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000097:blood*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010148:Intractable Pain / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D004304:Dosage Forms; D005283:Fentanyl